Weight Loss With Exenatide Treatment

NCT01590433 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2011P000310
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. The investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment. Hypothesis: The mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters. By identifying and following a group of obese women who lose greater than 5% body weight after short-term exenatide treatment, the investigators can gain insights into the possible mechanisms of weight loss and assess long-term weight loss with this pharmacotherapeutic intervention.

Conditions

Obesity

Keywords

Obesity; Overweight; Exenatide; Diet; Women

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.

  12 weeks

Study Arms (2)

Exenatide

EXPERIMENTAL

Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive exenatide will not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of study team will know which they are receiving.

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive placebo will be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of the study team will know which they are receiving.

Drug: Placebo; Behavioral: Dietary counseling

Interventions

Exenatide DRUG

Subjects will inject 5mcg of exenatide subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.

Exenatide

Placebo DRUG

Subjects will inject 5mcg of identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.

Placebo

Dietary counseling BEHAVIORAL

All subjects will also receive individualized dietary counseling. Subjects in the placebo group will be counseled to follow a hypocaloric diet.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females age 18-70
• BMI 28-48 kg/m\^2
• Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
• Ability to give informed consent and follow verbal and written instructions in English.

You may not qualify if:

• Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
• Unstable heart disease as evidenced by ongoing angina
• Congestive heart failure
• Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
• Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
• Tobacco, marijuana, cocaine, or intravenous drug use
• Shift workers (night shift or alternating day/night shifts)
• Gastroparesis
• Inflammatory bowel disease or irritable bowel syndrome
• Malignancy treated with chemotherapy within the past 3 years
• History of pancreatitis
• Depression requiring hospitalization or diagnosis of psychosis
• Renal insufficiency (eGFR less than 50)
• Transaminases greater than 2 times above the normal range
• Pregnancy within 6 months of the screening visit

Sponsors & Collaborators

• Jody Dushay: lead
• AstraZeneca: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Rodgers M, Migdal AL, Rodriguez TG, Chen ZZ, Nath AK, Gerszten RE, Kasid N, Toschi E, Tripaldi J, Heineman B, Phan M, Ngo L, Maratos-Flier E, Dushay J. Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women. Front Endocrinol (Lausanne). 2021 Nov 17;12:742873. doi: 10.3389/fendo.2021.742873. eCollection 2021.

  PMID: 34867786 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Exenatide; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Jody Dushay
• Organization: Beth Israel Deaconess Medical Center

jdushay@bidmc.harvard.edu

617-667-9344

Study Officials

• Eleftheria Maratos-Flier, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: May 3, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 23, 2021
• Results First Posted: February 12, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)